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Testosterone replacement therapy is able to reduce prostate inflammation in men with BPH, metabolic syndrome and hypogonadism: preliminary results from a randomized placebo-controlled clinical trial

Rastrelli, G1; Cipriani, S1; Lotti, F1; Cellai, I1; Comeglio, P1; Boddi, V1; Della Camera, P1; Palma, M1; Gacci, M1; Serni, S1; Maggi, M1; Vignozzi, L1

1: University of Florence, Italy

Objectives: BPH results from prostate tissue inflammation, which frequently occurs in men with metabolic syndrome (MetS). MetS is often associated with low testosterone (T). Recent evidence shows that low, rather than high, T levels are associated with BPH/lower urinary tract symptoms (LUTS). The aim of the study was to evaluate if T replacement therapy (TRT) for 6 months in BPH men with MetS and low T, is able to improve LUTS and prostate inflammation (as assessed by ultrasound and gene expression in prostate tissue).

Materials and Methods: 120 men in waiting list for BPH surgery and diagnosed with MetS were enrolled in the clinical trial. According to total T (TT) and calculated free T (cFT), they were categorized into eugonadal (TT≥12 nmol/L and cFT≥225 pmol/L; n=48) and hypogonadal men (TT<12 nmol/L and/or cFT<225 pmol/L; n=72). Hypogonadal men were randomly assigned to receive T gel 2% (5 g/daily) or placebo for 6 months. At baseline and follow-up visit (after 6 months), all men filled out the International Prostatic Symptoms Score (IPSS) and NIH-Chronic Prostatitis Symptom Index (NIH-CSPI) questionnaires and underwent a trans-rectal prostate ultrasound. After surgery, prostate tissue was collected.

Results: After adjusting for the baseline value, together with age, TT and waist circumference, NIH-CSPI total score significantly decreased in both the groups (p<0.001 vs. baseline), whereas IPSS total score did not change in any of the groups. IPSS bother score significantly decreased only in T-treated (p=0.042 vs. baseline value). Although a significant increase in total prostate and adenoma volume occurred in T-treated (both p<0.05 vs. the baseline value), T arm was characterised by a significant decrease in ultrasound markers of prostate inflammation, including arterial velocity and acceleration (both p<0.01 vs. baseline value). In a subset of patients (9 eugonadal, 11 placebo and 9 T-treated), the expression by prostate tissue of inflammatory markers was evaluated. COX2, MCP1 and RORC were found significantly decreased in T-treated as compared with placebo arm (all p<0.01) and for COX2 and MCP1 even in comparison with eugonadal men (both p<0.05).

Conclusions: Six-month treatment with T gel 2% in hypogonadal men with BPH and MetS is able to improve several clinical, ultrasound and molecular proxies of prostate inflammation. This results into a moderate improvement in symptoms, particularly prostatitis-like symptoms and bother for LUTS.


Work supported by industry: yes, by Kyowa Kirin (no industry support in study design or execution).

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